FDA Expands Smallpox Vaccine Approval Amid Mpox Epidemic

The U.S. FDA has approved Emergent BioSolutions' smallpox vaccine ACAM2000 for those at high risk of mpox infection. This marks the second approved mpox vaccine alongside Bavarian Nordic's Jynneos. The vaccine's approval comes as a new mpox strain spreads rapidly in Africa, prompting urgent global health measures.

The U.S. Food and Drug Administration has expanded its approval of Emergent BioSolutions' smallpox vaccine, ACAM2000, for individuals at high risk of mpox infection. This has led to a 15% surge in the drugmaker's shares before Friday's opening bell.

Announced late Thursday, the FDA's clearance makes ACAM2000 the second approved mpox vaccine in the U.S., following Bavarian Nordic's Jynneos. However, ACAM2000 is not suitable for individuals with weakened immune systems, such as those with HIV. The vaccine was underutilized during the 2022 mpox outbreak even though it was part of the U.S. stockpile.

The approval comes amid the rapid spread of a new mpox strain, clade Ib, in Africa. The World Health Organization recently declared mpox a global public health emergency for the second time in two years. Dr. Amesh Adalja from Johns Hopkins emphasized the urgent need to deploy all effective tools to combat this escalating epidemic. Emergent BioSolutions announced plans to donate 50,000 doses of ACAM2000 to African nations heavily impacted by the outbreak.

Last year, shares of Gaithersburg, Maryland-based Emergent BioSolutions suffered due to challenges in its contract manufacturing business. However, the company's stocks have tripled this year amid rising mpox concerns, job cuts, and the appointment of former Bausch CEO Joseph Papa to lead a turnaround.

(With inputs from agencies.)